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Adipose-Derived Biocellular Regenerative Therapy for Osteoarthritis
Sponsor: Healeon Medical Inc
Summary
Use of Biocellular and cellular approaches to treatment of Osteoarthritis (OA), musculoskeletal aging processes, pain, and degenerative changes are to be studied with minimally invasive protocols, and non-pharmaceutical means to relieve OA and its associated issues. Traditional surgical interventions have not yielded convincing long-term outcomes, including total joint replacement surgeries and medical management of the supportive structures. This study is to use a person's own stem/stromal Cells (autologous) plus HD-PRP (important healing growth factors and signal molecules) in such cases of OA for long-term minimally invasive treatments. Baseline (existing) findings are documented, and thence tracked as to progress deemed to be result of the intervention.
Official title: Adipose-Derived Biocellular Regenerative Therapy in Treatment of Osteoarthritis (OA) and Associated Connective Tissue Degeneration and Pain
Key Details
Gender
All
Age Range
18 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2020-01-10
Completion Date
2027-09-30
Last Updated
2024-10-01
Healthy Volunteers
No
Conditions
Interventions
Tissue Stromal Vascular Fraction (tSVF) Arm 1
Harvesting subcutaneous tSVF with sterile, disposable microcannula system
PRP Concentrate Arm 1
Preparation of PRP Concentrate via sterile Terumo-Harvest System
Tissue Stromal Vascular Fraction (tSVF) Arm 2
Harvesting subcutaneous tSVF with sterile, disposable microcannula system
PRP Concentrate Arm 2
Preparation of PRP Concentrate via sterile Terumo-Harvest System
Cellular Stromal Vascular Fraction (cSVF) Arm 2
Isolation-Concentration of cSVF via sterile enzymatic digestion (Liberase TM, Sterile Roche)
Cellular Stromal Vascular Fraction (cSVF) Arm 3
Isolation-Concentration of cSVF via sterile enzymatic digestion (Liberase TM, Sterile Roche)
Sterile Normal Saline (IV Solution)
Suspension of cSVF in 500 cc Sterile Normal Saline (IV Solution)
Locations (2)
Hemwall Center for Orthopedic Regenerative Medicine
Valencia, California, United States
Regenevita LLC
Stevensville, Montana, United States